Prescribing Information

For Patients

Engerix-B [Hepatitis B Vaccine (Recombinant)] is a vaccine used to help prevent Hepatitis B. Common side effects include pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness.

Engerix-B is administered by intramuscular injection. Consult your doctor for the vaccination dosing schedule. Engerix-B may interact with steroids, medicines to treat or prevent organ transplant rejection, or medications to treat psoriasis, rheumatoid arthritis, or other autoimmune disorders. Tell your doctor all medications and supplements you use and all vaccines you have recently received. During pregnancy, Engerix-B should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Engerix-B [Hepatitis B Vaccine (Recombinant)] Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

SIDE EFFECTS: Pain/soreness/redness/swelling at the injection site, fever, headache, tiredness, sore throat, nausea, diarrhea, loss of appetite, and dizziness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Infrequently, temporary symptoms such as fainting/dizziness/lightheadedness, vision changes, numbness/tingling, or seizure-like movements have happened after vaccine injections. Tell your health care provider right away if you have any of these symptoms soon after receiving an injection. Sitting or lying down may relieve symptoms.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US, you may report side effects to the Vaccine Adverse Event Reporting System (VAERS) at 1-800-822-7967. In Canada, you may report side effects to Health Canada at 1-866-234-2345.

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely
varying conditions, adverse reaction rates observed in the clinical trials of a
vaccine cannot be directly compared to rates in the clinical trials of another
vaccine and may not reflect the rates observed in practice.

The most common solicited adverse events were injection
site soreness (22%) and fatigue (14%).

In 36 clinical studies, a total of 13,495 doses of
ENGERIX-B were administered to 5,071 healthy adults and children who were
initially seronegative for hepatitis B markers, and healthy neonates. All
subjects were monitored for 4 days post-administration. Frequency of adverse events
tended to decrease with successive doses of ENGERIX-B.

Using a symptom checklist, the most frequently reported
adverse events were injection site soreness (22%) and fatigue (14%). Other
events are listed below. Parent or guardian completed forms for children and
neonates. Neonatal checklist did not include headache, fatigue, or dizziness.

Incidence 1% to 10% of Injections

Nervous System Disorders: Dizziness, headache.

General Disorders and Administration Site Conditions: Fever
( > 37.5°C), injection site erythema, injection site induration, injection
site swelling.

Postmarketing Experience

In addition to reports in clinical trials, worldwide
voluntary reports of adverse events received for ENGERIX-B since market
introduction (1990) are listed below. This list includes serious adverse events
or events which have a suspected causal connection to components of ENGERIX-B.

The following adverse events have been identified during
postapproval use of ENGERIX-B. Because these events are reported voluntarily
from a population of unknown size, it is not always possible to reliably
estimate their frequency or establish a causal relationship to the vaccine.